Abstract Background/Aims FILOSOPHY (NCT04871919) and PARROTFISH (NCT05323591) are ongoing, prospective, observational Phase 4 studies of filgotinib in patients with rheumatoid arthritis in Europe. In this interim analysis, pooled data from the studies are reported up to 2 years. Methods The studies enrolled adults with moderate to severe active RA who were prescribed filgotinib for the first time in daily practice. A ≥ 10-mm reduction in VAS pain score or a ≥ 4-point increase in FACIT-Fatigue score were considered clinically meaningful changes from baseline. Results From May 2021 to September 2024, 1,423 patients were treated with filgotinib (median follow-up: 550 days); baseline characteristics are shown in Table 1. 38.9% of patients were bDMARD naïve; 61.1% were bDMARD experienced. 91.2% received filgotinib 200 mg; 8.8% received filgotinib 100 mg. The proportion of patients with a CDAI score ≤10 increased from baseline to Month 24. In bDMARD-naïve patients, median (IQR) CDAI score decreased from 22.0 (16.0-31.0) at baseline (n = 424) to 8.0 (4.0-14.0) at Month 1 (n = 311), and in bDMARD-experienced patients from 24.0 (17.0-33.0) at baseline (n = 694) to 10.5 (6.0-18.0) at Month 1 (n = 444). Similar improvements were seen for DAS28-CRP. For PROs, median (IQR) HAQ-DI score decreased from 1.3 (0.8-1.8) at baseline (n = 335) to 0.8 (0.3-1.3) at Month 1 (n = 227) and 0.6 (0.3-1.1) at Month 18 (n = 73). A clinically meaningful change in VAS pain score occurred in 43.9% of patients (177/403) at Week 1 and 63.5% (54/85) at Month 24; for FACIT-Fatigue, the proportions were 43.6% (175/401) at Week 1 and 55.3% (47/85) at Month 24. Improvements in PROs were seen in bDMARD-naïve and -experienced patients. At Month 12, treatment persistence (95% CI) was 74.6% (72.1, 76.9) and 79.8% of patients had a CQR5 score 80%. There were 9 deaths, 7 of which were considered unrelated to study treatment by the investigator. Conclusion Patients treated with filgotinib in FILOSOPHY and PARROTFISH showed improvements in disease activity and HAQ-DI from Month 1, and in pain and fatigue from Week 1. At Month 12, treatment persistence was high (75%) and safety data were consistent with those previously reported from randomised controlled trials of filgotinib. Disclosure J. Galloway: Consultancies; AbbVie, Alfasigma S.p.A., Galapagos, Janssen, Lilly and Pfizer. Member of speakers’ bureau; AbbVie, Galapagos, Janssen, Lilly, Pfizer and UCB. Grants/research support; AstraZeneca, Janssen and Pfizer. J. Avouac: Consultancies; AbbVie and Galapagos. Member of speakers’ bureau; AbbVie, Alfasigma S.p.A., BMS, Celltrion, Eli Lilly, Galapagos, Novartis and Pfizer. Grants/research support; BMS, Fresenius Kabi, Novartis and Pfizer. N. Betteridge: Consultancies; Alfasigma S.p.A., Galapagos, Grünenthal, Ipsen and Sanofi. Member of speakers’ bureau; Galapagos, Grünenthal and Sanofi. K. Bevers: Consultancies; Alfasigma S.p.A. and Galapagos. G. Burmester: Member of speakers’ bureau; Celltrion, Chugai, Fersenius, Gedeon Richter and Sanofi. R. Caporali: Consultancies; Abbvie, Amgen, BMS, Celltrion, Eli Lilly, Fresenius Kabi, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz and UCB. Member of speakers’ bureau; Abbvie, Amgen, BMS, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Sandoz and UCB. O. Bouzid: Other; Employee of Alfasigma Belgium BV. T.P. Debray: Consultancies; Alfasigma S.p.A., Biogen, Daiichi Sankyo, Galapagos and Gilead. C. Van der Donckt: Other; Employee of Alfasigma Belgium BV. S. Romero Yuste: Consultancies; Astrazeneca. Member of speakers’ bureau; Astrazeneca. Grants/research support; CSL Vifor. P. Verschueren: Consultancies; Alfasigma S.p.A., Boehringer Ingelheim, Citryll, Eli Lilly and Galapagos. Member of speakers’ bureau; AbbVie, Eli Lilly and Galapagos. Grants/research support; Alfasigma S.p.A. and Galapagos.
Galloway et al. (Wed,) studied this question.